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\Director, Manufacturing

Region: Americas
Location:

Posted Date: 06/30/2022

Who We Are

Sirtex Medical is a fast-growing, dynamic global healthcare company with offices in Boston, Germany, Singapore, and Sydney, each aligned and working to improve patient outcomes in people living with cancer. Our current lead product utilizes a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. To date, patients with liver cancer across more than 1,300 medical centers in over fifty countries have collectively received over 100,000 doses of SIR-Spheres® Y-90 resin microspheres. Due to unprecedented growth and expansion, we are hiring a Director, Manufacturing.

What You’ll Do

The Director, Manufacturing is responsible strategic and operational leadership for all our existing and expansion manufacturing locations.

In this role, you’ll be responsible for ensuring the successful manufacture of all commercial and clinical products to enable product licensure and life cycle management. In addition, management of Plant Managers (currently there are 3) with cross functional collaborations with senior leadership in Regulatory, Quality, R&D and other key areas around the business.  

In this role, you’ll be responsible for ensuring the successful manufacture of all commercial and clinical products to enable product licensure and life cycle management. In addition, you’ll lead (3) Plant Managers with cross functional collaborations with other senior leadership in Regulatory, Quality, R&D as well as other key areas around the business.  Reporting to the global Head of Operations, you will be accountable for:

  • Define, shape and execute the manufacturing operation strategy to continuously improve and ensure a high level of compliance and the safety, efficacy, and quality of manufactured products in accordance with FDA Quality System Regulation, ISO, cGMP, and other applicable standards or regulations.
  • Develop and implement policies and programs designed to maximize capacity and ensure the highest quality at the lowest cost in a safe working environment.
  • Budget development and adherance to meet company strategy and objectives.
  • Lead collaborative strategic planning efforts for operations based upon performance and utilization of internal and external resources, pipeline progression, and continuous improvement to increase robustness and management of cost of goods.
  • Define and create appropriate metrics to track effectiveness of manufacturing goals & objectives and drive projects which show measurable progress in terms of production output, first pass yield, margins, scrap, non-conformances, cost, quality, budgeting and forecasting, as well as, the ongoing results of continuous improvement initiatives supporting cost and cycle time reductions.
  • Responsible for meeting or exceeding all operations and strategic business goals by conducting management reviews of manufacturing KPI’s, metrics, process performance indicators and quality system signals and supply risks.
  • Ensure systems/processes meet the needs of all internal and external partners with an emphasis on process, quality, productivity, budget control, and profitability.
  • Ensure that all-critical and major issues, which may have an adverse effect on the quality of the product or represent a risk of supply are escalated as per standard and are resolved within stated timelines. Initiate corrective actions when necessary and perform follow-up on resulting measures.
  • Coordinate with R&D to support product transition from clinical to commercial and support the introduction of new products into manufacturing, assisting with vendor selection, manufacturing partnerships, and production transfer.
  • Manage the design, development, validation and manufacture of device and combination products from introduction to the clinic through registration and commercial support.
  • Collaborate with sales and clinical operations departments to create production volume plans and ensure smooth operations and optimal use of facilities & resources to meet agreed sales forecasts within cost budgets. Accountable for all aspects of manufacturing of Sirtex product(s) e.g. SIR-Spheres Microspheres and associated delivery apparatus.
  • Proactive change agent with a focus on continuous improvement and delivering best practices in manufacturing, improving process parameters by championing a variety of systems, process and cost reduction initiatives designed to increase overall efficiencies and ensure maximum productivity.
  • Plan and lead supplier manufacturing capability assessments, lead identification & mitigation activities of vulnerabilities within the supplier base, and propose & lead process / product improvement efforts for suppliers.
  • Build operations, logistics, and supply chain teams who are flexible and adaptable with the ability to support increasing volumes and efficiently handle new science and technologies as a result of acquisitions and/or alliances, from both a manufacturing and supply chain perspective.
  • Recruit, retain and develop first class, diverse, equitable, and inclusive team. Build and sustain employee engagement by creating a culture and environment in which individuals and teams can excel and continuously improve.
  • Ensure all activities are performed in a safe, compliant manner, meeting regulatory, radiation safety requirements and local EH&S requirements.
  • Develop and maintain strong and effective relationships with partners including Supply Chain, Sales & Marketing, Regulatory Affairs, Program Leadership, Human Resources, Legal, and Finance to ensure corporate goals are met.
  • In collaboration with the Global Head of Operations, serve as a core member of the team responsible for planning for scale up globally in accordance with developed budgets and forecasts.
  • Establish an effective preventative maintenance plan for all key production equipment.
  • Responsibility for OH&S within production and distribution.
  • Ensure production OH&S training is in accordance with business needs.
  • Ensure production of Sirtex product at all sites is performed in accordance with good manufacturing practices and quality system requirements.
  • Responsibility for product and process development associated with improved production.

Who You’ll Be

To be successful in this role, we’ll require that you have:

  • Bachelors’ degree in Science, Engineering or related discipline
  • 15 years experience in a medical device with experience leading global manufacturing operations and networks
  • Experience scaling medical device manufacturing and fulfillment operations in high growth environment
  • Management of diverse and multidisciplinary teams
  • Successful track record of leading integration and manufacturing transfer
  • Six-Sigma Black Belt desired
  • Proven track record of building and advancing Manufacturing infrastructure globally
  • Experience leading, building and developing high impact multidisciplinary teams
  • Financial reporting skills and overall business acumen
  • Excellent written and verbal skills and ability to influence others across the organization.
  • Strong interpersonal and collaboration skills demonstrated in a global setting
  • Execution focused, able to move from hands on tasks to providing guidance to the team and in turn enable it to achieve success
  • Strong track record in effectively building and managing a high performing team to achieve stretch goals, while not afraid to hold others accountable and give them timely and direct feedback
  • Thorough knowledge of the current quality and regulatory requirements for medical devices required; knowledge of isotopes/radiation desired
  • Experience commercializing new pharmaceutical or medical device products and life cycle management of globally distributed commercial products
  • Experience in construction and build out of operations facilities
  • Ability to build strong networks within the organization, influence, gain buy in, and implement change at all levels, cross functionally
  • Ability for significant overseas and domestic travel – 40-50%
  • Ability to work off hours as dictated by global requirements

What To Expect at Sirtex

If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
  • A working culture of respect, diversity, and performance to help facilitate an inclusive culture
  • Attractive compensation and benefit packages which are practical, robust, fair and equitable
  • A place to grow through career development and training opportunities
  • Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world

Compensation and Benefits 

Sirtex Medical has been named a best-in-class employer in the United States after scoring in the top quartile of large and midsize employers who participated in Gallagher’s 2021 Benefits Strategy & Benchmarking Survey. Sirtex was recognized as an organization that provides innovative solutions for creating organizational structures, workplace policies and total rewards, which inclusively engage and motivate its employees.

Gallagher’s Best-in-Class awards recognize employers that excel in supporting their employees’ physical, emotional, career and financial wellbeing for better organizational outcomes. “The HR team and I are passionate about creating a culture that cares about you and your family’s wellbeing,” said Sirtex Chief Human Resources Officer Cathleen Lowndes. “Our benefit program in the US is special and something I think we can all be proud of. While we still have opportunities to continue investing, we have made a number of noteworthy upgrades in the past few years.”

Recent upgrades to U.S. Benefits at Sirtex include:

  • Implemented Flexible Work Policy 
  • Added domestic partner benefits
  • Provide adoption assistance resources
  • Upgraded our EAP program to provide you more mental health/wellness options
  • Purchased a la carte hearing benefit
  • Evolved our leave policies to be inclusive 
  • Added an additional medical plan to lower medical premium costs passed on to you
  • Launched Own Your Career – $4000/per employee for professional development

“We take a proactive and structured approach to planning, developing and implementing comprehensive benefits and HR programs,” explained Cathleen. “We believe supporting our workforce builds our overall organizational strength and resilience. Without a doubt – we know that our people are the most important asset of Sirtex. “

Conditions of Employment

  • Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations. Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
  • Physical requirements include sitting, walking, standing for prolonged periods, possible radiation exposure.
  • Willingness to:
    • Participate in all relevant formal training events.
    • Observe and comply with all Sirtex corporate policies.
    • Work within, and ensure adherence to quality system procedures, work instructions, and other quality systems.
    • Work within, and ensure adherence to health, safety, and environmental management system procedures, instructions, and other necessary factors.

Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, I accordance with applicable law.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.                                                                                          

Apply Now!

Be part of an amazing team that is helping to save lives, every day.